Teams at Parexel

Lead regulatory strategy across programs and portfolios, advise on authority engagement and submission strategies, coordinate high-impact regulatory submissions, develop lifecycle and long-range development plans, align regulatory approaches with clinical and commercial teams, and monitor regulatory landscape changes to inform development decisions.

Lead end-to-end planning, execution, and delivery of complex global oncology and inflammation clinical trials. Provide trial team leadership, oversee feasibility, vendor management, compliance (GCP/regulatory), recruitment and risk mitigation, data delivery, TMF archiving, and support reporting/publication activities while liaising with cross-functional and external stakeholders.

Lead clinical data management for assigned studies, ensuring timely deliverables (Go-Live to Database Lock). Coordinate cross-functional stakeholders, manage risks, metrics, contracts, quality/compliance (ICH-GCP), audits, resourcing, and training. Support bid pursuits and represent Data Management to sponsors.